With its tailor-made turnkey technological solutions based around the ZSK twin screw extruder, Coperion is responding to the growing demand from the pharmaceutical industry for systems for continuous production processes that offer higher efficiency and uniformity than batch processes. One example of this is a complete pharmaceutical system with a ZSK 18 MEGAlab twin screw extruder with an 18 mm screw diameter that was recently delivered to an international pharmaceutical company. This fully integrated system includes two Coperion K-Tron gravimetric loss-in-weight feeders with superior accuracy in API and liquid feeding, a cooling belt, and a Coperion Pelletizing Technology strand pelletizer. With a maximum throughput rate of 10 kg/h, it is suitable for both wet extrusion and continuous hot-melt extrusion (HME) on a laboratory scale. In the implementation of this system, Coperion leveraged its experience that spans over 30 years in specialty applications for recipe development as well as large production systems for this demanding industry. April 17-19, 2018 Coperion presents its technological solutions at Interphex 2018 (New York, NY, USA, Booth 2261).
Precise, reproducible product quality
One reason for the continually increasing importance of HME processing in the pharmaceutical industry is its intensive mixing effect, as offered by Coperion’s co-rotating ZSK twin screw extruders. As a result, active substances and excipients can be dispersed very finely and homogeneously in pharmaceutical polymers without the use of solvents, which promotes a high degree of bioavailability of the APIs (also BCS classes 2 & 4). In addition, the self-wiping screw profile of these systems eliminates dead spaces. Due to the specific torque of 11.3 Nm/cm3 which allows low ratios of throughput to screw speed, the thermal stress on the APIs and polymers in the ZSK process section is low. Combined with the customized peripheral equipment, these systems make it possible to precisely adhere to the recipe and to create a reproducibly high product quality. In addition, process steps, such as encapsulation or taste masking, can be integrated into the process.
Highly accurate and customized feeding of the ingredients
The integration of the Coperion K-Tron feeders for complete systems ensures optimal dispensing of the formulation ingredients. Coperion K-Tron is known for its highly accurate feeding solutions for pharmaceutical applications. The feeders, which are available as volumetric or gravimetric models, demonstrate a high level of reliability, especially in continuous processes. The wide range of feeder designs makes it possible to feed a very wide range of materials – from the finest powders and pellets to liquids and pastes – to a pharmaceutical process very precisely. Suitable feed systems are even available for ingredients with demanding properties, such as poorly flowing or sticky materials, flooding powders, temperature-sensitive liquids, or substances with a high hazard potential. For complex recipes, several feeders can be grouped around an extruder inlet.
At this year’s Interphex, Coperion K-Tron is pleased to display the newest innovation in pharmaceutical feeder design. The new feeder and scale combination includes modularity for quick feeder exchange, easier access and cleanability, as well as a smaller footprint, ideal for multi feeder clustering around continuous processes.
All Coperion K-Tron feeders have always been specifically designed to meet the stringent requirements of this industry, including compliance with GMP guidelines and the use of FDA-approved construction materials.
Modular system provides maximum flexibility
All ZSK pharmaceutical extruders have a compact design, are easy to operate, and offer optimal accessibility for cleaning and maintenance. For maximum flexibility when feeding liquids and devolatilizing the melt, Coperion uses a modular design for the process section, which includes several barrels in which the co-rotating screws operate. The size-independent Do/Di ratio (outer screw diameter to inner screw diameter) of 1.55 allows reliable scale-up. The systems are designed to comply with GMP guidelines. Customers receive complete documentation for all process parameters (V-Lifecycle) based on a URS (User Requirement Specification).
Precise pelletizing solutions
Coperion Pelletizing Technology offers suitable pelletizers that are specifically designed for pharmaceutical applications. The systems are characterized by their high level of reliability and product quality and have proven themselves many times in practice. Appropriate materials and surfaces are used in order to meet the high requirements of the pharmaceutical industry. Special attention is paid to making the systems easy to access and to clean. Other features, such as pellet length adjustment, can also be realized.
Stefan Gebhardt, General Manager of Business Unit Food & Pharma at Coperion, says: “Like all industries, the pharmaceutical industry is constantly striving to increase process efficiency. Our continuously operating ZSK extrusion systems offer interesting potential, as they increase productivity in comparison to conventional batch processes without compromising on quality, and they require less space. The FDA also supports the trend towards continuous processes because they can accelerate product development and reduce production time. And, as the last link in the chain, patients also benefit from the use of our extruders because the intensive dispersing effect can increase the bioavailability of the incorporated pharmaceuticals, and therefore optimize the effect.”
RFID access control in hazardous areas
Fast and secure access to processes
Security and access control are given top priority in the production process, as unauthorised users and operating errors can cause great damage. R. Stahl is the only manufacturer in the market offering its explosion-protected Thin Clients with RFID authentication for secure identification of staff with access authority for process control and data communication from the field. On the basis of three technology platforms, the Thin Clients have been designed to meet the different requirements of the chemical and pharmaceutical industries, the food industry as well as oil and gas production.
Additional logins in the automation system are no longer required due to the faster, direct RFID access control, which meets the current security requirements according to FDA and Gamp. It supports transponders with Mifare, Desfire, EV1 or Legic Advant reader technologies. Unlike biometric processes, the contactless RFID technology is also suitable for hygienically sensitive areas where obligatory protective clothing makes authorisation via fingerprint or face recognition impossible. R. Stahl’s explosion-protected RFID readers have been certified for Zones 1/21 and 2/22. They are either available as separate units with a USB interface for panel mounting, or they are integrated directly into the operator enclosures or keyboards by the manufacturer.
The Thin Clients designed for the oil and gas industry with the Shark technology device platform and 21.5″ touchscreens are also available with a RFID reader installed behind the front plate. User authorisation via RFID requires the installation of a suitable device driver in the control system software. On request, the company will provide cards and key fobs equipped with tested transponders for use in hazardous areas.
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Dialogue between manufacturers and users
Satisfied customers through integration
35 Open Integration partners gathered together at Endress + Hauser in Reinach, Switzerland, to share their experiences and thoughts for the first time. A highlight of the event was a presentation from representatives of the chemical and pharmaceutical industries outlining how they benefit from the partner program during digitalization of their processes – and what they would like to see in the future.
The goal of the Open Integration program initiated by Endress + Hauser can be summed up quickly: the simple, fast and manufacturer-independent integration of components and devices into various automation systems. And, almost more importantly, satisfied customers.
While it sounds simple in theory, when it comes to day-to-day system operation, it’s far from that. Even the most experienced automation specialists have great respect for multi-vendor systems. That also applies to complete solutions “from a single source.” After all, digital communications – a precondition for the extensive use of existing intelligence in field devices and systems – places serious demands on integration.
With its Open Integration partner program, Endress + Hauser is inviting providers of control technology, fieldbus infrastructure, measurement technology and actuator systems to test and document the interaction of their products even more extensively in the interests of their customers. The cooperation partners include Auma Riester, Bürkert, Festo, Flowserve, Hima Paul Hildebrandt, Honeywell Process Solutions, Mitsubishi Electric, Pepperl + Fuchs, Phoenix Contact, Rockwell Automation, Schneider Electric and Turck.
Open standards as a basis
The foundation of this effort is open communication standards (Hart, Profibus, Foundation Fieldbus, EtherNet/IP or Profinet), as well as open integration standards (FDT, EDD, FDI). With a nearly unlimited selection of options, the reference topologies represent practical combinations suitable for applications in the chemical, life sciences, food & beverage, oil & gas, power & energy, primaries & metal and water & wastewater industries.
The reference topologies take into account industry-typical requirements such as explosion protection, availability and redundancy. Each topology is thoroughly tested and documented in the lab in Reinach in conjunction with the partners, after which the recommendations are published.
Interoperability tests create added value
And how do customers benefit from the Open Integration partner program? Every problem that the integration experts discover prior to commissioning can be resolved at a much lower cost compared to fixing the issue in the field at some later point. Customers receive concrete, validated recommendations for automating their systems, which go well beyond established conformity and interoperability testing while ensuring seamless integration. Last but not least, they save time and money.
With developments such as IIoT and APL, users will face new challenges, plus integration testing will be given added weight. This makes it even more important for the Open Integration partners to work together over the long term. The participating customer and provider representatives were in full agreement on this point. Cyber security, in addition to the issue of connectivity, will play a key role in the future. They furthermore agreed that effective strategies need to be developed to counter new entrants in the automation industry such as IBM or Amazon.
One thing was clear during the get-together in Reinach in early June: the process control industry wants open, interoperable systems instead of proprietary solutions. One of the users wants uniform, structured access to static information via QR- and RFID-supported type plates in accordance with DIN 91406. Standardized diagnostics in line with NE 107 is also at the top of the wish list.
In the near term, Endress + Hauser wants to work with its partners to address these and other open issues with the aim of utilizing Open Integration to offer customers even more value-add during digitalization of their processes. The common goal: satisfied customers who can extensively utilize the opportunities that digitalization brings with little risk.
The ideal connection
In the manufacture of metal bellows couplings, bellows and hub connections are a critical issue. While steel or stainless steel couplings can be combined with a special micro plasma welding process, this method is not suitable for combinations of aluminum and steel. Adhesive bonding processes can be used here, but they can fail under extreme operating conditions (chemicals, very high or low temperatures). Especially in the case of clutches on the input side of a planetary gear, high temperatures can occur in critical applications which could loosen the adhesive bonds.
The developed and long-time patented joining process (crimping-in-press process), on the other hand, is optimally suited for connecting multi-layer stainless steel bellows without clearance to aluminum hubs. Here the operation is certainly possible even in temperature ranges from -50 ° C to + 350 ° C.